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Novo Nordisk

Pharmaceutical companyAI in United StatesAI. FDA records under 12 spellings of its name, each linked to the record. See the Novo Nordisk group view.

  • Records across the group: 76, 4 entitiesAI
  • Drug applications: 31
  • 510(k) clearances: 20
  • Drug recalls: 17
  • OPDP letters: 3

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Novo Nordisk and its 3 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Mar 5, 2026Warning letter: CAPACDERWarning letters
Feb 26, 2026Untitled letter: OZEMPICOffice of Prescription Drug PromotionOPDP letters
Feb 5, 2026Untitled letter: WegovyOffice of Prescription Drug PromotionOPDP letters
Dec 19, 2025Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, PrClass II · Presence of Particulate Matter: Hair was found in a prefilled syringeDrug recalls
Dec 19, 2025Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Class II · Presence of Particulate Matter: Hair was found in a prefilled syringeDrug recalls
Sep 9, 2025Warning letter: DrugsCDERWarning letters
Sep 9, 2025Warning letter: WegovyOffice of Prescription Drug PromotionOPDP letters
Jul 10, 2024Complete response letter, BLA 761326UnapprovedComplete response letters
Aug 25, 2023NovoFine® PlusK231255 · FMI510(k) clearances
Apr 24, 2023Complete response letter, BLA 761315ApprovedComplete response letters
Jun 23, 2021NovoFineK210258 · FMI510(k) clearances
Dec 19, 2020NovoFine Plus 32G Tip x 4 mmK202005 · FMI510(k) clearances
Dec 17, 2018NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)K182387 · FMF510(k) clearances
Jan 17, 2018NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)K173479 · FMI510(k) clearances
Jul 5, 2017Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for siClass II · A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.Device recalls
Oct 18, 2016NovoPen EchoK162602 · FMF510(k) clearances
Jul 31, 2015NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)K150874 · FMF510(k) clearances
May 21, 2014NOVOFINE PLUS 32G 4 MMK133738 · FMI510(k) clearances

Subsidiaries and Divisions

3 firms in the Novo Nordisk group, most records first

Canada and Imports

Across the Novo Nordisk group, matched by company name
Active Health Canada device licences
7, as of Nov 10, 2026
FDA import refusals since 2024
373 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
NOVO NORDISK INCNovo Nordisk IncNovo Nordisk, Inc.NOVO NORDISKNovo Nordisk Inc.Novo NordiskNovo Nordisk A/S
FEI numbers in warning letters
2244771
Wikidata
Q818846

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.